HealthyPhase 1NCT02266940
Relative Bioavailability DS-1971a Suspension and Tablets and Food Effect on DS-1971a Tablets
A Phase 1 study testing DS-1971a suspension and DS-1971a tablet in people with Healthy, run by Daiichi Sankyo at 1 site in United Kingdom.
Trial summary
This is an open label, randomised, 3 treatment, 3 period crossover study. This study is designed to assess the relative bioavailability of DS 1971a from a tablet formulation and a reconstituted oral suspension and the effect of a high fat meal on the relative bioavailability of DS 1971a from the tablet formulation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DS-1971a suspension and DS-1971a tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 to 65 years, inclusive
- Subjects must be in good general health as determined by medical history, physical examination and screening investigations, and be taking no regular medication
- A body mass index (BMI) in the range 18 to 30 kg/m^2, inclusive, and weighing between 50 and 100 kg. BMI is calculated as weight [kg]/(height [m])^2
- Female subjects must be of nonchildbearing potential as follows:
- Must be postmenopausal (the last menstrual period was at least 12 months before Screening, and a follicle stimulating hormone [FSH] test at Screening confirms postmenopausal status); or Must be surgically sterile having undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy and/or bilateral tubal ligation
- Willing and able to consume a standard Food and Drug Administration (FDA) high fat meal
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- Willing to comply with all study restrictions, including the use of contraception, concomitant medication, and dietary and lifestyle restrictions
- Sufficient intelligence to understand the nature of the study and any hazards of participating in it. Ability to communicate satisfactorily with the Investigator and to participate in, and comply with the requirements of, the entire study
- Have given written consent to participate after reading the information and consent form, and after having the opportunity to discuss the study with the Investigator or his/her delegate
- Have given written consent to have his/her data entered into The Over-volunteering Prevention System (TOPS)
Who cannot join
- Clinically relevant abnormal history, physical findings, ECG findings, or laboratory values that could interfere with the objectives of the study or the safety of the subject
- Presence of or history of acute or chronic illness, including (but not limited to) liver or kidney disease, hypertension, seizures, or any known impairment of endocrine, or other specific body-organ dysfunction
- Presence or history of severe adverse reaction to any medicine
- Presence or history of malignant disease
- Acute or chronic infectious disease, including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or C virus (HCV) infection
- Surgery (eg, stomach bypass) or medical condition that might affect absorption of medicines
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- Significant illness within 4 weeks before the dose of study medication
- Participation in another clinical study of a new chemical entity or a prescription medicine within the previous 3 months, or unwilling to abstain from participating in other clinical studies during the study and for 3 months after receipt of their final dose of study medication
- Participation in another clinical study with DS-1971a
- Blood pressure (BP) and heart rate in semi supine position at the screening examination outside the ranges 90-140 mmHg systolic, 40-90 mmHg diastolic; heart rate 40-100 beats/min. Subjects with Stage 1 hypertension (systolic 140 160 mmHg; diastolic 90 100 mmHg) may be enrolled provided they do not have evidence of end organ damage, diabetes or a 10 year cardiovascular risk >20%
- Estimated glomerular filtration rate (eGFR) <80 mL/min/1.73m^2 or an absolute creatinine value above the upper limit of normal (ULN). eGFR will be estimated at Screening using the modification of diet in renal disease (MDRD) equation
- Abnormal ECG waveform morphology at Screening that would preclude accurate measurement of the QT interval duration
- Corrected QT interval (Fridericia's formula) (QTcF) interval duration >430 msec for men or >450 msec for women, obtained as an average from the measurements on duplicate screening ECGs
- Use of any prescription medicine or over-the-counter (OTC) medications, herbal remedies (such as St John's Wort), or food known to be strong inhibitors or strong inducers of cytochrome (CYP) enzymes (also known as CYP450 enzymes) during the 30 days before the dose of study medication; use of any other prescription or OTC medicine, including dietary supplements or herbal remedies, during the 7 days before the first dose of study medication
- Consumption of certain foods or beverages before the dose and throughout the study period
- Loss of more than 400 mL blood during the 3 months before the study, eg, as a blood donor
- Abuse of drugs or alcohol during the 2 years before the first dose of study medication, or intake of more than 21 units of alcohol weekly (for men) or 14 units of alcohol weekly (for women)
- Use of tobacco products or nicotine containing products during the 3 months before the dose of trial medication
- Likely possibility that the volunteer will not cooperate with the requirements of the protocol
- Objection by General Practitioner (GP) to volunteer entering the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Medicines Research Ltd
London, NW10 7EW
About this study
Official title: A Phase 1, Open Label, Randomised, Single Dose, Three Way Crossover Study to Explore the Relative Bioavailability of DS 1971a Given as a 200 mg Tablet Formulation and a 200 mg Oral Suspension, and to Explore the Effects of Administration With a High Fat Meal on the Relative Bioavailability of the Tablet Formulation
This is an open label, randomised, 3 treatment, 3 period crossover study. This study is designed to assess the relative bioavailability of DS 1971a from a tablet formulation and a reconstituted oral suspension and the effect of a high fat meal on the relative bioavailability of DS 1971a from the tablet formulation.
- Conditions
- Healthy
- Being tested
- DS-1971a suspension, DS-1971a tablet
- Keywords
- pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-1971a suspensionDrug
DS 1971a will be supplied as a powder or crystals and prepared at the study site for administration as an oral suspension with a taste masking agent.
DS-1971a tabletDrug
A 200 mg DS 1971a tablet for oral administration
| Study group | Role | What they receive |
|---|---|---|
| 200mg DS-1971a oral suspension fasted | Experimental | 200 mg DS 1971a given as oral suspension in fasted condition Receives: Drug: DS-1971a suspension |
| 200 mg DS-1971a tablet fasted | Experimental | single 200 mg DS 1971a oral tablet in fasted condition Receives: Drug: DS-1971a tablet |
| 200 mg DS-1971a tablet fed | Experimental | single 200 mg DS 1971a oral tablet given in fed condition Receives: Drug: DS-1971a tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics profile of DS-1971a
Plasma concentration time data will be analysed using non compartmental methods. The following PK parameters will be estimated: Cmax, Tmax and AUClast. If data permit, AUC0-inf, CL/F, Vd/F and T½ will be estimated.
Measured: 3 days from dose administration
Secondary outcomes (3)
number and severity of adverse events as a measure of safety and tolerability
number and severity of adverse events as a measure of safety and tolerability
Measured: administration of first dose to 10 weeks
changes in clinical laboratory profile
haematology, biochemistry, and urinalysis
Measured: administration of first dose to 10 weeks
changes in physical exam profile
Physical examination profile includes; Height and weight, heart rate, blood pressure (BP), oral temperature and respiration rate, 12 lead electrocardiogram (ECG)
Measured: administration of first dose to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266940
- Sponsor's protocol ID
- DS1971-A-E104
- Status last verified
- Jan 2015
- First submitted
- 9 Oct 2014
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Randomised, Single Dose, Three Way Crossover Study to Explore the Relative Bioavailability of DS 1971a Given as a 200 mg Tablet Formulation and a 200 mg Oral Suspension, and to Explore the Effects of Administration With a High Fat Meal on the Relative Bioavailability of the Tablet Formulation
- ClinicalTrials.gov ID
- NCT02266940
- Acronym / sponsor ID
- DS1971-A-E104
- Conditions
- Healthy
- Keywords
- pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, randomised, 3 treatment, 3 period crossover study. This study is designed to assess the relative bioavailability of DS 1971a from a tablet formulation and a reconstituted oral suspension and the effect of a high fat meal on the relative bioavailability of DS 1971a from the tablet formulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200mg DS-1971a oral suspension fasted | Experimental | Drug: DS-1971a suspension200 mg DS 1971a given as oral suspension in fasted condition |
| 200 mg DS-1971a tablet fasted | Experimental | Drug: DS-1971a tabletsingle 200 mg DS 1971a oral tablet in fasted condition |
| 200 mg DS-1971a tablet fed | Experimental | Drug: DS-1971a tabletsingle 200 mg DS 1971a oral tablet given in fed condition |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects aged 18 to 65 years, inclusive
- Subjects must be in good general health as determined by medical history, physical examination and screening investigations, and be taking no regular medication
- A body mass index (BMI) in the range 18 to 30 kg/m^2, inclusive, and weighing between 50 and 100 kg. BMI is calculated as weight [kg]/(height [m])^2
- Female subjects must be of nonchildbearing potential as follows:
- Must be postmenopausal (the last menstrual period was at least 12 months before Screening, and a follicle stimulating hormone [FSH] test at Screening confirms postmenopausal status); or Must be surgically sterile having undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy and/or bilateral tubal ligation
Key exclusion criteria (20 listed)
- Clinically relevant abnormal history, physical findings, ECG findings, or laboratory values that could interfere with the objectives of the study or the safety of the subject
- Presence of or history of acute or chronic illness, including (but not limited to) liver or kidney disease, hypertension, seizures, or any known impairment of endocrine, or other specific body-organ dysfunction
- Presence or history of severe adverse reaction to any medicine
- Presence or history of malignant disease
- Acute or chronic infectious disease, including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or C virus (HCV) infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS-1971a suspensionDS 1971a will be supplied as a powder or crystals and prepared at the study site for administration as an oral suspension with a taste masking agent. | Drug | 200mg DS-1971a oral suspension fasted |
| DS-1971a tabletA 200 mg DS 1971a tablet for oral administration | Drug | 200 mg DS-1971a tablet fasted, 200 mg DS-1971a tablet fed |
Primary outcome
Pharmacokinetics profile of DS-1971a
Time frame: 3 days from dose administration
Plasma concentration time data will be analysed using non compartmental methods. The following PK parameters will be estimated: Cmax, Tmax and AUClast. If data permit, AUC0-inf, CL/F, Vd/F and T½ will be estimated.
3 secondary outcomes
number and severity of adverse events as a measure of safety and tolerability
Time frame: administration of first dose to 10 weeks
changes in clinical laboratory profile
Time frame: administration of first dose to 10 weeks
changes in physical exam profile
Time frame: administration of first dose to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DS-1971a suspension and DS-1971a tablet in people with Healthy, run by Daiichi Sankyo at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics profile of DS-1971a (time frame: 3 days from dose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.